# FDA 483 - Gaoyou Qinyou Biological Technology Co., Ltd. - October 18, 2021

Source: https://www.globalkeysolutions.net/records/483/gaoyou-qinyou-biological-technology-co-ltd/33734718-ded1-40b1-9225-eb17f4322bf4

> FDA 483 for Gaoyou Qinyou Biological Technology Co., Ltd. on October 18, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Gaoyou Qinyou Biological Technology Co., Ltd.
- Inspection Date: 2021-10-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection, Gaoyou Qinyou Biological Technology Co., Ltd., an API manufacturer in Yangzhou, China, was cited for deficiencies in equipment cleaning and maintenance. Inspectors observed a production tank labeled as cleaned that contained rust-like spots and lubricant spills on product contact areas, indicating a failure to follow established cleaning procedures. These findings raise concerns about the firm's adherence to quality standards for its crude heparin sodium products.

## Related Officers

- [Dennis Cantellops Paite](https://www.globalkeysolutions.net/people/dennis-cantellops-paite/3336bbb8-8520-4a8a-9085-76e7a55ca773)

Company: https://www.globalkeysolutions.net/companies/gaoyou-qinyou-biological-technology-co-ltd/f334d92a-f001-48a5-b8de-a93a54171329

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1